This invention relates generally to methods and apparatus for treating incontinence and more specifically relates to methods and apparatus for providing an inflatable artificial sphincter for control of excretory body passages.
A known treatment for some cases of incontinence is to provide an individual with a mechanism to occlude the affected excretory body passage. These mechanisms are typically surgically implanted within the individual and are adapted to be operable by the individual to selectively open and occlude the body passage and to ease coping with the incontinence.
Inflatable artificial sphincters are one known form of such mechanism. Inflatable sphincters typically include an inflatable cuff for surrounding the passage to be occluded. One or more pumps cooperatively associated with a fluid reservoir are utilized to transfer fluid into and out of the cuff. As fluid is pumped into the cuff, the cuff inflates and closes the circumscribed body passage. One difficulty with inflatable sphincters concerns their implantation within the patient. When the cuff of the device is initially placed around the intended body passage, the passage is irritated by the foreign body. If the cuff is inflated during the period in which the passage adapts to the presence of the cuff, the likelihood of erosion and/or scarring occlusion of the passage is significantly increased. It is therefore desirable to maintain the cuff in an uninflated condition while the passage adapts to the presence of the cuff.
One type of inflatable artificial sphincter which offers significant benefits to the patient is a semi-automatic functioning sphincter wherein the pump transfers fluid from the cuff to a fluid reservoir to open the body passage. The fluid then gradually returns to the cuff over a limited period of time to refill the cuff and occlude the body passage. This refilling occurs without the necessity of any additional manipulation by the individual. Thus, the manipulation of a single pump facilitates the desired continence to the individual. Because prior art types of these sphincters allow the cuff to reinflate automatically, various techniques have had to be adapted to protect the body passage during the adaption period.
Previously utilized techniques for maintaining the cuff in an uninflated condition during the initial adjustment period have included implanting the inflatable sphincter without the fluid used to inflate the cuff. After the period of adaptation has passed, the sphincter is filled with fluid and allowed to function normally. Another technique for maintaining the cuff in an uninflated condition which has been utilized is to implant an auxiliary occluding mechanism around the tubing connecting the sphincter reservoir to the pump. This auxilary occluding mechanism is added solely for occluding the artificial sphincter tubing and does not form a part of the artificial sphincter itself. This mechanism is utilized to occlude the tubing and to thereby lock the fluid into the reservoir. The auxiliary occluding mechanism is then later released to allow normal operation of the sphincter. Both of these techniques require an additional surgical procedure to place the sphincter in normally operating condition. This is inefficient and inconvenient for both patient and physician.
Accordingly, the present invention provides a new method and apparatus whereby fluid may be selectively locked out of the cuff of an inflatable sphincter by an externally operable mechanism, and whereby such mechanism is repeatedly operable to perform such lock-out function or to allow normal operation of the sphincter.